Marking World Menopause Day on 19 October, the South African Menopause Society (SAMS) has raised concerns about the use of compounded bioidentical hormone therapy (CBHT), which is unregulated, and doesn’t undergo the strict checks and testing that standard treatments do
SAMS suggests using the term “compounded menopausal hormone therapy” (CMHT) to describe this unregulated treatment, because the word “bioidentical” is not a scientific term, but one used in marketing: the accepted global term is “menopausal hormone therapy” (MHT) to indicate a treatment that has been approved and regulated by government agencies.
Regulated Menopausal Hormone Therapy (MHT) is recommended by major menopause societies to treat symptoms including hot flushes, genitourinary syndrome of menopause (GSM), and to help to prevent bone loss and fracture.
Risks and benefits of MHT are clearly described in the mandatory, enclosed information pamphlet.
Individualised treatment, using evidence-based research, can optimise benefits and minimise patient risks. All MHT regimens should be evaluated regularly.
Many women believe that CMHT contains hormones that are more “natural” than those in regulated MHT. Nevertheless, these hormones can be present in both regulated and unregulated treatments, and can also be referred to as body-similar or body-identical hormones.
Another concern with CMHT is the potential inconsistency in its formulation. Since CMHT is mixed specifically for an individual, its formulations can differ significantly from one batch to another, lacking standardisation and raise safety concerns.
This may also lead to over- or under-dosing. Government-regulated medications undergo strict checks to ensure they’re safe and effective. The regulatory rules apply both to new formulations and those that have already been approved.
Every country will have its own guidelines concerning manufacture, as well as the testing of each medication which includes extensive research, testing, marketing and ongoing oversight in order to ensure patient safety.
Regulated and approved MHT contains approved amounts of appropriate hormones and are carefully checked. They come with detailed information about their use and potential side effects.
CMHT is not standardised or regulated by an approved government body and doesn’t undergo these checks. The formulations of CMHT may vary widely from batch to batch and there’s no standardisation or assurance of quality, safety, and efficacy.
Regulated MHT is distributed with appropriate package inserts and safety warnings, while CMHT does not provide these. Reports on side effects with CMHT are voluntary, so there’s limited data on its safety and efficacy.
Major menopause societies do not recommend CMHT. Claims that CMHT is safer than government-approved treatments are not supported by scientific evidence. In a few cases, CMHT might be an option for some women who are allergic to ingredients in standard treatments or if specific dosages aren’t available.
It’s important for healthcare professionals to understand the differences between regulated and unregulated MHT, and to inform their patients about the potential risks associated with unregulated treatments.
Issued by the South African Menopause Society